Radar on Specialty Pharmacy
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Califf: Industry Support Will Be Key To FDA’s Prospects Under Trump
How the FDA fares during President-elect Donald Trump’s second term will depend, in part, on the pharmaceutical industry’s support for the agency and its staff, Commissioner Robert Califf told the Friends of Cancer Research annual meeting on Nov. 12.
Califf’s second term as commissioner will end when Trump takes office in January.
“This not the first time I’ve ridden out of town after an election,” he joked.
Califf said the incoming administration clearly is intent on changing a lot of things, but “how it gets changed depends on who gets appointed to the key positions and how the various policies play out.”
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Prime Report: Oncology Medical Benefit Drugs Continue to Drive Trend
Medical benefit per-member per-month (PMPM) trend continued to increase last year in commercial, Medicare and Medicaid lines of business. That’s one of the findings from Prime Therapeutics LLC’s 14th annual Medical Pharmacy Trend Report, which also unsurprisingly revealed that oncology is the top category of PMPM spend in all three lines of business. And while biosimilars continue to pull share from their oncolytic reference drugs, next year may be the first year to see nononcology medical benefit biosimilars pick up share, pointed out an industry expert at a recent webinar.
Previously known as the Magellan Rx Management Medical Pharmacy Trend Report, the recently released report includes information on 2023 health plan paid claims data on provider-administered medical benefit drugs, which make up more than half of total drug spending in the U.S.
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New FDA Approvals: FDA Approves First Abraxane Generic
Oct. 8: The FDA approved Sandoz Inc.’s paclitaxel for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. It is the first FDA-approved generic of Abraxane from Abraxis BioScience LLC, a division of Bristol Myers Squibb. The agent is available as a 100 mg single-dose vial of lyophilized powder. Recommended dosing is 260 mg/m2 via a 30-minute intravenous infusion every three weeks. Drugs.com lists the price of one 100 mg vial of Abraxane as more than $1,673.
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News Briefs: Gilead Withdraws Trodelvy in Urothelial Cancer
Gilead Sciences Inc. is voluntarily withdrawing the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, the company said on Oct. 18. Other indications for the Trop-2-directed antibody-drug conjugate are not affected. The FDA granted the accelerated approval on April 13, 2021, based on tumor response rate and duration of response in a Phase II single-arm trial. Earlier this year, the company revealed that a Phase III confirmatory trial did not meet the primary endpoint of overall survival in the intention-to-treat population.
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PBM Private-Label Units Bring Promise of Biosimilar Competition, Scrutiny
At the beginning of next year, the last of the Big Three PBMs will join the others in offering a new private-label subsidiary. Those units, which are largely focused on biosimilars and generics, have the potential to boost biosimilar competition and improve pricing, but such arrangements also are drawing scrutiny, most recently from the Senate Finance Committee.
On Jan. 1, 2025, UnitedHealth Group’s Optum Rx will place Nuvaila-labeled biosimilars of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine and AbbVie Inc.’s Humira (adalimumab) on various tiers of three of its commercial formularies for a zero-dollar copay. In partnership with Amgen Inc. for its interchangeable Wezlana (ustekinumab-auub), Wezlana for Nuvaila will be available in both high-wholesale acquisition cost and low-WAC versions.
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